MAJOR TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b sulfat ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

Major Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic First Aid to help prevent infection in - minor cuts - scrapes - burns deep or puncture wounds animal bites serious burns - in eyes - over large areas of the body - if you are allergic to any of the ingredients - If you need to use longer than 1 week - The condition persists or gets worse - A rash or allergic reaction develops

Authorization status:

OTC monograph final

Summary of Product characteristics

MAJOR TRIPLE ANTIBIOTIC- BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B
SULFAT OINTMENT
MAJOR PHARMACEUTICALS
----------
MAJOR TRIPLE ANTIBIOTIC OINTMENT
ACTIVE INGREDIENT
Bacitracin Zinc 400 Units
PURPOSE
First Aid Antibiotic
ACTIVE INGREDIENT
Neomycin 3.5 mg
PURPOSE
First Aid Antibiotic
ACTIVE INGREDIENT
Polymyxin B Sulfate 5000 Units
PURPOSE
First Aid Antibiotic
USES
First Aid to help prevent infection in
minor cuts
scrapes
burns
WARNINGS
FOR EXTERNAL USE ONLY.
ASK DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns
DO NOT USE
in eyes
over large areas of the body
if you are allergic to any of the ingredients
STOP USE AND ASK DOCTOR IF
If you need to use longer than 1 week
The condition persists or gets worse
A rash or allergic reaction develops
DIRECTIONS
Clean the affected area
Apply a small amount of the product (an amount equal to the surface
area of the tip
of a finger) on the area 1 to 3 times daily
May be covered with a sterile bandage
INACTIVE INGREDIENTS
mineral oil and white petrolatum
QUESTIONS
Call 1-800-616-2471
STORAGE INFORMATION
Avoid excessive heat and humidity
Store at room temperature 15° to 30°C (59° to 86°F).
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)
right away.
OTHER INFORMATION
Tamper evident. Do not use if packet is torn, cut or opened.
Distributed By:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive
Suite 233
Livonia, MI 48152
Product of USA
PACKAGING
MAJOR TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin, polymyxin b sulfat ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:0904-8805
Major Pharmaceuticals
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN
3.5 mg in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
BACITRACIN
400 [USP'U] in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B -
UNII:J2VZ 07J96K)
POLYM